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FDA 510(k)

FLUID DISPENSING SYSTEM

K-Number: K800362 · 1980-03-12

ApplicantPharmaseal Laboratories
Decision Date1980-03-12
Product CodeKYX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLUID DISPENSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaseal Laboratories. It received FDA 510(k) clearance on 1980-03-12 under 510(k) number K800362. The device is classified under product code KYX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUID DISPENSING SYSTEM?

FLUID DISPENSING SYSTEM is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Pharmaseal Laboratories. The 510(k) number is K800362.

When did FLUID DISPENSING SYSTEM receive FDA 510(k) clearance?

FLUID DISPENSING SYSTEM received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800362.

Who is the listed applicant for FLUID DISPENSING SYSTEM?

The FDA 510(k) record lists Pharmaseal Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUID DISPENSING SYSTEM?

The FDA product code for FLUID DISPENSING SYSTEM is KYX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pharmaseal Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K800737DEBRISAN (DEXTRANOMER) PASTEK801146SAMPLING KITK800874PELVIC EXAM TRAYK760469CLEANSING AGENT, NEW WOUND (DEBRISSU)

Related Devices (Code: KYX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K980109CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSERSangstat Medical Corp.K954181CANYONS BI-DIRECTIONAL CHECK VALVECanyon Medical ProductsK830571BOTTLE ADAPTERBurron Medical Products, Inc.K801008MULTI-AD FLUID DISPENSING PUMP MP-3000Burron Medical Products, Inc.K800437SYRINGE TIP CONNECTORBurron Medical Products, Inc.K792227MULTI-AD FLUID DISPENSING SYSTEMNational Patent Development Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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